The study is also examining the effects of epoetin on cognitive function in
these women, said Joyce O’Shaughnessy, MD, associate director, US Oncology
Research, Baylor-Charles A. Sammons Cancer Center, Dallas. She discussed the
data in a presentation at the Chemotherapy Foundation Symposium XIX (abstract
74).

The 100 women in the study are being assessed for cognitive function at
baseline just before cycle 4 of chemotherapy and 6 months after treatment ends.
Two tests are used to evaluate executive control function, a frontal lobe
function that involves multitasking or "putting together simple tasks into
a complex sequential behavior," she said.

The EXIT 25 test asks 25 questions to determine executive control function,
while CLOX is a simpler tool. The rationale for using both was to determine
whether the simpler CLOX could substitute for EXIT 25 in future studies.
Quality of life was measured with the FACT-An and the Linear Analog Scale, and
mood with the Profile of Mood States.

Dr. O’Shaughnessy noted that past studies of cognitive function in breast
cancer patients receiving adjuvant chemotherapy failed to stratify for
menopausal and hormone therapy status. This is important, she said, because
chemotherapy-induced menopause or estrogen-therapy withdrawal can also lead to
impaired memory and concentration.

"We stratified the women by menopausal status as well as whether they
had recently stopped hormone replacement therapy," she said. "We
really tried to control that variable as best we could."

All patients in the study received four cycles of anthracycline-based
chemotherapy. Adriamycin/cyclophosphamide (AC) was the most common chemotherapy
regimen in the trial, Dr. O’Shaughnessy said. Adriamycin-taxane regimens
were also used. Patients were randomized in a double-blind fashion to receive
40,000 units per week of epoetin given subcutaneously from the beginning of
chemotherapy or placebo.